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# FDA Approves New Heart Valve Repair Device Indication
- URL: https://www.fdaweb.com/fda-approves-new-heart-valve-repair-device-indication/
- Published: 2019-03-14T12:00:00.000Z
- Updated: 2026-09-15T01:12:35.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143614

FDA has approved a new indication for the Abbott Vascular MitraClip for treating patients with normal mitral valves who develop heart failure symptoms and moderate-to-severe or severe mitral regurgitation because of diminished left heart function despite being treated with optimal medical therapy. An agency [statement](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm633479.htm?utm%5Fcampaign=031419%5FPR%5F%20valve%20repair%20device&utm%5Fmedium=email&utm%5Fsource=Eloqua) says the MitraClip was first approved in 2013 with an indication to reduce mitral regurgitation in certain patients whose significant mitral regurgitation and heart failure symptoms result from primary or degenerative mitral regurgitation and whose risks for mitral valve surgery are prohibitive.

The statement says the MitraClip is inserted in a minimally invasive procedure through the femoral vein and guided into the heart’s left ventricle, where it grasps the two leaflets of the mitral valve, clipping them together to reduce the backflow of blood.

Approval of the new indication was based on a study of 614 patients with heart failure who had moderate-to-severe or severe secondary mitral regurgitation and were randomly assigned to either continuation of their optimized medical treatment plus the MitraClip or continuation of their medical treatment only. FDA says the risk for re-hospitalization for heart failure symptoms was reduced by about 47% in the MitraClip group compared to the control group. And the risk of death within two years was decreased by about 37% in the MitraClip group compared to the control group.

Potential adverse events from the device and implant procedure include death, stroke, major bleeding, and atrial fibrillation, the notice says. The MitraClip is contraindicated in patients who cannot tolerate blood thinners during or after the procedure, who have endocarditis of the mitral valve, rheumatic mitral valve disease, or evidence of blood clots in the heart or veins leading to the heart.